FDA.reportPublic FDA data

H&H Compressed Gauze

Primary DI
10857048006368
Brand
H&H Compressed Gauze
Company
H&H MEDICAL CORPORATION
Model
1
Catalog number
HHPG
Device description
H&H Compressed Gauze, containing a 4.5" x 4 yds (stretched) roll of crinkle fluff cotton gauze for use in wound management.
Published
2020-12-31
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NABGauze / Sponge,Nonresorbable For External Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NABGauze / Sponge,Nonresorbable For External UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10857048006368PackageGS1175In Commercial Distribution
00857048006361PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085704800636810857048006368
00857048006361008570480063618570480063610857048006361

GMDN Terms#

Term, Definition table
TermDefinition
First aid gauze/bandageA wound cover intended to be used as an initial, short-term treatment after injury. It typically consists of a gauze pad (e.g., cotton wool or lint) that is attached to a roll bandage (e.g., cotton or cotton/viscose). The pad is applied directly to the wound, and the bandage is subsequently wrapped around the pad and secured. The device is intended for use in the home or a clinical setting to protect wounds, arrest bleeding, and introduce medications placed on the pad. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
804-642-3663info@gohandh.com

Regulatory Flags#

DUNS number
072656713
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00857048006064H&H Big Cinch Abdominal Bandage1BC012020-07-10
00857048006095H-Bandage Compression Dressing, Flat Fols1HBFF012020-07-10
00857048006101Thin H Compression Bandage, Standard Fold1HBT012020-07-10
00857048006118Thin H Compression Dressing, Flat Fold1HBTF2020-07-10
00857048006125Mini Compression Bandage1HHMCB012020-07-10
00857048006057H&H Situation Instrument Tray Kit1HHSIT012020-07-06
00857048006392SWAT-T Elastic Tourniquet, Black1SWAT-T-BLK-EA2020-12-31
00857048006422SWAT-T Elastic Tourniquet, Orange1SWAT-T-BLK-EA2020-12-31
00857048006316TK-4 Elastic Tourniquet1TK-42020-12-31
00857048006323TK-4L Elastic Tourniquet1TK-4L2020-12-31
00857048006484H&H Combat Medic Tape1CMRT012020-12-31
00857048006361H&H Compressed Gauze1HHPG2020-12-31
00857048006521H&H Flat Compressed Gauze1HHPF2020-12-31
00857048006538H&H TACgauze Wound Wrapping Gauze1TACG022020-12-31
00857048006545H&H MiniTAC Wound Wrapping Gauze1HHMTG012020-12-31
00857048006088H-Bandage Compression Dressing - Rolled1HB012020-07-10
00857048006583H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006590H&H Mini 2X Bandage/Gauze Combo Pack1HHM2X2021-03-17
00857048006132Bolin Chest Seal6BCS012020-12-31
00857048006552H&H 30fr Nasopharyngeal Airway, Each1.0HHNPA-EA2020-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975675784750RESCUE RESSENTIALSEMSRUN GROUPNAB2026-09-22
00810194401671AiraAIRA, LLCNAB2026-08-26
06979931947972TempoXuchang Zhende Surgical Dressing Co., Ltd.NAB2026-08-21
06979032641168Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
06979032641175Thomas Jane MedicalHUZHOU JUNDA INDUSTRY CO., LTD.NAB2026-06-27
00197344173993CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00197344174006CURADMEDLINE INDUSTRIES, INC.NAB2026-06-24
00840456203330JMUJMU DENTAL, INCNAB2026-06-23
00840456203347JMUJMU DENTAL, INCNAB2026-06-23
00840456203354JMUJMU DENTAL, INCNAB2026-06-23
00840456224199JMUJMU DENTAL, INCNAB2026-06-23
00840456224205JMUJMU DENTAL, INCNAB2026-06-23
06924105625026BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
06924105625033BOENMEDBOEN HEALTHCARE CO., LTD.NAB2026-06-03
G242YCBJMR9Techno-AideTechno-Aide, Inc.NAB2025-09-12
G242YCAYMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCCCMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCETMR9Techno-AideTechno-Aide, Inc.NAB2025-09-10
G242YCADMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAKMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCASMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBHMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCBOMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCDAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCEPMR9Techno-AideTechno-Aide, Inc.NAB2025-09-09
G242YCAAMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCABMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCACMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05
G242YCAEMR9Techno-AideTechno-Aide, Inc.NAB2025-09-05