FDA.reportPublic FDA data

Steri-Pocket

Primary DI
00850071154023
Brand
Steri-Pocket
Company
Hanes Companies, Inc.
Model
SP300
Published
2025-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850071154023PrimaryGS10
00850071154030Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850071154023008500711540238500711540230850071154023
00850071154030008500711540308500711540300850071154030

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument guard, single-useA device designed to be used with a surgical or invasive instrument to protect the instrument from damage and/or the operator or patient from injury. It is typically made of metal or plastic materials and available in a variety of designs. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
139362420
Device count
100
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850071154436Instrument OrganizerCSDH5122025-10-22
00850071154450Instrument OrganizerCSDH5122025-10-22
00850071154368Instrument OrganizerCSDH1002025-10-22
00850071154382Instrument OrganizerCSDH1022025-10-22
00850071154399Instrument OrganizerCSDH1052025-10-22
00850071154405Instrument OrganizerCSDH3002025-10-22
00850071154412Instrument OrganizerCSDH2002025-10-22
00850071154443Instrument OrganizerCSDH5052025-10-22
00850071154290Steri-PocketCSDH5052025-08-19
00850071154306Steri-PocketCSDH5122025-08-19
00850071154313Steri-PocketCSDH2002025-08-19
00850071154320Steri-PocketCSDH3002025-08-19
00850071154337Steri-PocketCSDH1052025-08-19
00850071154344Steri-PocketCSDH1022025-08-19
00850071154351Steri-PocketCSDH1002025-08-19
00850071154078Steri-PocketSP100ST2025-07-16
00850071154115Steri-PocketSP300ST2025-07-16
00850071154139Steri-PocketSP105ST2025-07-16
00850071154153Steri-PocketSP200ST2025-07-16
00850071154177Steri-PocketSP505ST2025-07-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776433840MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433857MillenniumAvalign Technologies, Inc.MDM2026-10-08
00190776433673MillenniumAvalign Technologies, Inc.MDM2026-10-07
00190776436162MillenniumAvalign Technologies, Inc.MDM2026-10-07
G141526051160Carnegie Surgical LLCCarnegie Surgical LLCMDM2026-10-07
00190776433536MillenniumAvalign Technologies, Inc.MDM2026-10-06
00190776434311MillenniumAvalign Technologies, Inc.MDM2026-10-06
00810220800584Adler Instrument CompanyAdler, Inc.MDM2026-09-30
00190776432775MillenniumAvalign Technologies, Inc.MDM2026-09-29
00888867618961Arthrex®ARTHREX, INC.MDM2026-09-28
00888867621237Arthrex®ARTHREX, INC.MDM2026-09-28
10888277689251MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689268MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689282MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689299MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689305MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689312MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689329MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689336MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689343MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277689350MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
20888277689272MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-28
10888277688988MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689190MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689206MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689213MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689220MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689237MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
10888277689244MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27
20888277688978MEDLINEMEDLINE INDUSTRIES, INC.MDM2026-09-27