Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1222274

FEI Number

1000121057

Entity Name

DESIGN STANDARDS CORP.

City/State/Country

CHARLESTOWN, NH, US

Establishment Address

957 Claremont Rd, CHARLESTOWN, NH 03603, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DESIGN STANDARDS CORP. (Owner Number: 1220100)

Owner / Operator Contact Address

957 Claremont Road, Charlestown, NH 03603, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Xpansion(R) Ocular Platform Wound Dressing Platform Wound Dressing VBAS Extension Arm Gravity Syndesmosis EndoFloating Ball EFB3 Xpansion(R) SURELINE SKIN STAPLE EXTRACTOR ConMed 883590 Endo-Lapra- Ty ABS Clip Applier Circular Sizer Ring Curette StaXx XD System EndoSH2 Sealing Hook DS3 Dissecting Sealer DS3.5-C Dissecting Sealer Platform Wound Dressing for NPWT Xpan Universal Trocar System ProToe Xpansion (R) Platform Wound Dressing DeRoyal ConMed 893590 Xpansion (R) Xpansion (R)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GAF	Spatula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2014-02-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-04-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-04-08
GDJ	Clamp, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2013-10-25
HTN	Washer, Bolt Nut	Orthopedic	Class 2	888.3030	2021-03-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-13
FZT	Cutter, Surgical	General, Plastic Surgery	Class 1	878.4800	2014-02-13
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2002-02-05
GDO	Applier, Surgical, Clip	General, Plastic Surgery	Class 1	878.4800	2013-01-09
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2017-06-05
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2020-08-24
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2021-03-11
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2012-12-13
OMP	Negative Pressure Wound Therapy Powered Suction Pump	General, Plastic Surgery	Class 2	878.4780	2019-04-08
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2026-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2021-03-11
FZW	Expander, Surgical, Skin Graft	General, Plastic Surgery	Class 1	878.4800	2014-02-13
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-04-08
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2021-05-04
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2014-02-13
GFD	Dermatome	General, Plastic Surgery	Class 1	878.4820	2014-02-13

Official Correspondent

ERIC CRAINICH

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

DESIGN STANDARDS CORP.

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
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1222274. Last updated year: 2026. Please use registration number 1222274 when referencing this establishment in official correspondence.