FDA.reportPublic FDA data

Thomas Jane Medical

Primary DI
06979032641175
Brand
Thomas Jane Medical
Company
HUZHOU JUNDA INDUSTRY CO., LTD.
Model
TJM53
Device description
Surgical Sponges (Non-Woven), .5"x3" (X-Ray Detectable), 10pcs/pack
Published
2026-06-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

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
16979032641172PackageGS120In Commercial Distribution
26979032641179PackageGS1400In Commercial Distribution
06979032641175PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1697903264117216979032641172
2697903264117926979032641179
06979032641175069790326411756979032641175

GMDN Terms#

Term, Definition table
TermDefinition
Radiopaque non-woven surgical spongeA non-medicated device made from a non-woven absorbent material (e.g., rayon/polyester) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It is intended to produce less lint than woven gauze and contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.

Regulatory Flags#

DUNS number
452976115
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
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
06979032641168Thomas Jane MedicalTJM132026-06-27
06979032640017GOBENJD12-U0301012025-08-26
06979032640024GOBENJD13-H0401012025-08-26
06979032640031GOBENJD14-R4901072025-08-26
06979032640048GOBENJD14-R2801032025-08-26
06979032640055GOBENJD14-R4301062025-08-26
06979032640062GOBENJD05-N0801022025-08-26
06979032640079GOBENJD04-C1401052025-08-26
06979032640086GOBENJD05-N0401022025-08-26
06979032640093GOBENJD05-N2301062025-08-26
06979032640109GOBENJD01-B0102032025-08-26
06979032640116GOBENJD14-R3901012025-08-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06979032641168Thomas 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
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