FDA.report

Gems

Primary DI
00618125160488
Brand
Gems
Company
TIDI PRODUCTS, LLC
Model
20862F
Device description
Gems Dome Bags Clear Polyethylene Sterile 1in x 1in x 1in 20 per Case
Published
2022-09-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
PUIDrape, Surgical, Exempt

Product Code Classifications

CodeDeviceSpecialtyClass
PUIDrape, Surgical, ExemptGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10618125160485PackageGS120In Commercial Distribution
01618125160487PreviousGS10
00618125160488PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
1061812516048510618125160485
01618125160487016181251604871618125160487
00618125160488006181251604886181251604880618125160488

GMDN Terms

TermDefinition
Medical equipment drape, single-useA flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or equipment components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the contents from soiling and contamination when used in the vicinity of, or entered into, a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
063519193
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 DIBrandModelCatalogPublished
10618125192325POSEY8334WL8334WL2025-12-04
10618125192318AquaGuard50000-SMP50000-SMP2025-09-23
20618125192308Carina570-5439570-54392025-09-22
10618125187123VALO466846682025-08-29
10618125187130VALO466746672025-08-29
10618125187147VALO466646662025-08-29
80618125188716VALO100636610063662025-08-29
80618125188723VALO100636710063672025-08-29
80618125188730VALO100636810063682025-08-29
10618125189950VALO466946692025-08-29
80618125190177VALO100980810098082025-08-29
10618125190185VALO466546652025-08-29
20618125114669Sirona20809B63101202025-07-10
10618125192264Steris31780BF458 (056404-710)2025-07-01
10618125192271Steris31780 N/SBF459 (056404-709)2025-07-01
20618125192254Posey806080602024-12-23
00618125192144Grip-Lok3300MWA-10PK3300MWA-10PK2024-12-02
00618125192175Grip-Lok3400LFC-10PK3400LFC-10PK2024-12-02
00618125192182Grip-Lok3400L-10PK3400L-10PK2024-12-02
00618125192199Grip-Lok3300M-10PK3300M-10PK2024-12-02

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
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20748426264494Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
10748426264503Medline-MicrotekMicrotek Medical LLCPUI2026-03-16
00634916019353Standard SupremeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916120905Instrument HolderSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916781373WrapPel Table CoverSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916870633Instrument DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881202Circumcision Drape,STANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881226Split DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
00634916881233T-Lap Fenestrated DrapeSTANDARD TEXTILE CO., INC.PUI2026-03-11
04052199810164Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810188Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04052199810201Foliodrape Protect PlusPAUL HARTMANN AGPUI2026-03-09
04255575119459Sterile Cover KitRaguse Gesellschaft für medizinische Produkte mbHPUI2026-03-03
50198956294569CARDINAL HEALTHCardinal Health 200, LLCPUI2026-03-02
10748426261540NAMicrotek Medical LLCPUI2026-02-26
20197344179487MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10197344179497MEDLINEMEDLINE INDUSTRIES, INC.PUI2026-02-23
10748426144577Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144638Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144645Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144690Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144737Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144744Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426144751Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145468Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145475Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145505Medline-MicrotekMicrotek Medical LLCPUI2026-02-18
10748426145512Medline-MicrotekMicrotek Medical LLCPUI2026-02-18