Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3018052045

FEI Number

3018052045

Entity Name

AKSHAR GAMMA STERILES LLP

City/State/Country

THANE Maharashtra, IN

Establishment Address

PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,, THANE Maharashtra 421506, IN

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

AKSHAR GAMMA STERILES LLP (Owner Number: 10084053)

Owner / Operator Contact Address

PLOT NO N-13, NEAR WATSON PHARMA CO, ADDL MIDC ANAND NAGAR, AMBERNATH EAST,, THANE, IN-MH 421506, IN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

PLAIN/REDIGUT® PLAIN PRO; REDISILK® PRO; REDILON® PRO; REDIBOND® PRO REDISORB® FAST PRO; MERISOFT CHROMIC/REDIGUT® CHROMIC PRO; MERISOFT Mirus Ligating Clip Filamide Latitude Hip Replacement System (Acetabular Cup System) Latitude Hip Replacement System (Acetabular Cup System) MIRUS Linear Stapler (Gun) Latitude Hip Replacement System (Triad Acetabular Cup System & Proximally coated un-cemented femoral stem) MITSU FST

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAS	Suture, Nonabsorbable, Synthetic, Polyester	General, Plastic Surgery	Class 2	878.5000	2022-12-28
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2022-12-28
HMN	Suture, Nonabsorable, Ophthalmic	Unknown	Class 3	N/A	2022-12-28
GAN	Suture, Absorbable, Synthetic	General, Plastic Surgery	Class 2	878.4830	2022-12-28
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2022-12-28
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2022-12-28
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-12-28
GAO	Suture, Nonabsorbable	General, Plastic Surgery	Class 2	878.4495	2022-12-28
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2022-12-28
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2022-01-12
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2022-01-12
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-12-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-12-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-12-29
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2022-12-29
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-12-29
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2022-12-29
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2022-12-28
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2022-12-29
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2022-12-28
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-12-28

Official Correspondent

No official correspondent registered.

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

AKSHAR GAMMA STERILES LLP

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K221629	Covidien	Tri-Staple 2.0 Black Circular Reloads (for use with Signia Circular Adapters)	2023-02-22
K231491	Covidien	TA Stapler and Loading Unit with DST Series Technology	2023-08-16

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2009	Surgical Specialties Corp	2	3-0 Black Mono Nylon Suture, 12 units per box. product number 925B. The product intended for use in general soft tissue approximation and/or ligation including use in ophthalmic procedures.
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3018052045. Last updated year: 2026. Please use registration number 3018052045 when referencing this establishment in official correspondence.