FDA.report

USMEDCO

Primary DI
08600036785722
Brand
USMEDCO
Company
US MEDCO INC
Model
GT00119
Device description
SPONGE LAP WASHED NO LOOP
Published
2023-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
GDYGauze/Sponge, Internal, X-Ray Detectable

Product Code Classifications

CodeDeviceSpecialtyClass
GDYGauze/Sponge, Internal, X-Ray DetectableGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08600036785272PrimaryGS10
08600036785340PrimaryGS10
08600036785418PrimaryGS10
08600036785586PrimaryGS10
08600036785654PrimaryGS10
08600036785722Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08600036785272086000367852728600036785272
08600036785340086000367853408600036785340
08600036785418086000367854188600036785418
08600036785586086000367855868600036785586
08600036785654086000367856548600036785654
08600036785722086000367857228600036785722

GMDN Terms

TermDefinition
General-purpose surgical spongeA non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, cotton, cellulose) 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 or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
178219445
Device count
90
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
50192253050293VistecCardinal Health 200, LLCGDY2026-03-05
10815555025678CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025685CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025661CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025630CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025623CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025647CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
10815555025654CypressMCKESSON MEDICAL-SURGICAL INC.GDY2025-12-16
50198956239690CARDINAL HEALTHCardinal Health 200, LLCGDY2025-11-28
10850049994863Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994870Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994887Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994894Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994900Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994917Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994924Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994931Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994948Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994955Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994962Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994979SynterventionZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-26
10850049994993Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-23
10850049994986Syntervention ZIEN MEDICAL TECHNOLOGIES, INC.GDY2025-09-22
37613327465854SurgiCount Safety-SpongeSTRYKER CORPORATIONGDY2025-09-03
06979032640079GOBENHUZHOU JUNDA INDUSTRY CO., LTD.GDY2025-08-26
30193489015991MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-12
40888277338914MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079747MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079754MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06
40193489079822MEDLINEMEDLINE INDUSTRIES, INC.GDY2025-06-06