FDA.reportPublic FDA data

PRIMED

Primary DI
00842942012761
Brand
PRIMED
Company
priMED Medical Products Inc
Model
PM1-1112
Device description
P100 Strength Sterilization Wrap, 12in x 12in, 30.5cm x 30.5cm, Purple+Purple
Published
2026-05-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
FRGWrap, Sterilization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRGWrap, SterilizationGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10842942012768PackageGS12In Commercial Distribution
00842942012761PrimaryGS10
90842942012764Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084294201276810842942012768
00842942012761008429420127618429420127610842942012761
9084294201276490842942012764

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization packaging, single-useA device, typically in the form of a paper sheet, envelope, bag, wrap, or similar, intended to be used to contain medical devices that are to be sterilized. It is designed to allow sterilization of the enclosed medical device and also to maintain sterility of the device until the packaging is opened for use of the device, or until a predetermined shelf date is expired. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in cool, dry, and well ventilated space out of direct sunlight.

Regulatory Flags#

DUNS number
253287569
Device count
240
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00842942011047PRIMEDPM4-571932025-07-15
00842942013386PRIMEDPM1-23452026-05-15
00842942001888PRIMEDPG4-16802025-07-14
00842942003806PRIMEDPG4-16402025-07-14
00842942007910PRIMEDPG4-25012025-07-14
00842942008467PRIMEDPM4-58493XL2025-07-15
00842942011788PRIMEDPM4-581932025-07-15
00842942012389PRIMEDPG4-19212025-07-14
00842942015700PRIMEDPM4-571922025-07-17
00842942015717PRIMEDPM4-57192XL2025-07-17
00842942016530PRIMEDPM4-581922025-07-21
00842942017230PRIMEDPM4-68374XL2025-07-15
00842942017261PRIMEDPM4-571912025-07-17
00842942017278PRIMEDPM4-57191XL2025-07-17
00842942017483PRIMED / CaracalCPS10732025-11-20
05391534524441PRIMEDPM4-57372C2025-07-15
00842942008894PRIMEDPG4-49932026-06-21
00842942013485PRIMEDPM1-33542026-06-04
00842942013645PRIMEDPM1-34242026-06-04
00842942013652PRIMEDPM1-34362026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10724995240650V. MuellerSteris CorporationFRG2026-09-24
20888277115511GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20884389190460GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20888277115566GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-09
20080196921413GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-03
20080196921482GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
20884389188290GeminiMEDLINE INDUSTRIES, INC.FRG2026-09-02
00810194400766AiraAIRA, LLCFRG2026-08-26
00810194403637AiraAIRA, LLCFRG2026-08-26
00810194403644AiraAIRA, LLCFRG2026-08-26
00810194403651AiraAIRA, LLCFRG2026-08-26
00810194403668AiraAIRA, LLCFRG2026-08-26
00810194403675AiraAIRA, LLCFRG2026-08-26
00810194403699AiraAIRA, LLCFRG2026-08-26
00810194403712AiraAIRA, LLCFRG2026-08-26
00810194403729AiraAIRA, LLCFRG2026-08-26
00810194403736AiraAIRA, LLCFRG2026-08-26
08404535030853Brasseler USAPeter Brasseler Holdings, LLCFRG2026-08-21
10724995233386V. MuellerSteris CorporationFRG2026-08-21
00724995241858V. MuellerSteris CorporationFRG2026-08-18
00724995241865V. MuellerSteris CorporationFRG2026-08-18
00724995241872V. MuellerSteris CorporationFRG2026-08-18
00724995241889V. MuellerSteris CorporationFRG2026-08-18
00840118614245Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614252Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614269Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614276Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614283Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614290Endure IndustriesENDURE INDUSTRIESFRG2026-08-14
00840118614306Endure IndustriesENDURE INDUSTRIESFRG2026-08-14