Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003639970

FEI Number

3003639970

Entity Name

B. BRAUN SURGICAL, S.A.

City/State/Country

RUBI Barcelona, ES

Establishment Address

CARRETERA DE TERRASSA 121, RUBI Barcelona 08191, ES

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

B. Braun Surgical, S.A. (Owner Number: 10030447)

Owner / Operator Contact Address

Carretera de Terrassa, 121, Rubi, ES-B 08191, ES

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K133890

PMA Number

N/A

All Registered Proprietary Names

MANIPLER AZ

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2018-03-22
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2013-01-24
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2022-05-09
NWJ	Suture, Recombinant Technology	General, Plastic Surgery	Class 2	878.4494	2011-05-20
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2011-06-09
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2013-06-12
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2016-02-18
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2012-02-14
MPN	Tissue Adhesive For The Topical Approximation Of Skin	General, Plastic Surgery	Class 2	878.4010	2014-07-30
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2013-01-07
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2018-03-09
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2011-06-09
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2011-06-09
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2009-10-06
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2009-10-06
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2017-06-13
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2014-08-26

Official Correspondent

No official correspondent registered.

US Agent Details

Kamaal Anas Business: Aesculap Inc Email: kamaal.anas@bbraunusa.com Phone: (610) 9849071

Related Public Records

Same Entity

B. Braun Surgical, S.A.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3025308493	B. BRAUN SURGICAL, S.A.	Rubi Barcelona, ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K072322	Smith & Nephew, Inc.	ULTRA FAST-FIX AND ULTRA FAST-FIX AB MENISCAL REPAIR SYSTEMS	2007-09-18
K241486	Covidien	Sofsilk Coated Braided Silk Suture	2024-12-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - 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 3003639970. Last updated year: 2026. Please use registration number 3003639970 when referencing this establishment in official correspondence.