FDA.reportPublic FDA data

PMI

Primary DI
10812608020253
Brand
PMI
Company
PROGRESSIVE MEDICAL, INC.
Model
PMISG12B2
Catalog number
PMISG12B2
Device description
PMI Suture Guide Bariatric Length (12mm - 2 Holes) - Reusable
Published
2016-09-23
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
false

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812608020253PackageGS14In Commercial Distribution
00812608020256PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081260802025310812608020253
00812608020256008126080202568126080202560812608020256

GMDN Terms#

Term, Definition table
TermDefinition
Nonimplantable needle guide, reusableA non-powered device designed to lead a needle into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization;Ethylene Oxide

Regulatory Flags#

DUNS number
192135242
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812608022328PMIPMICC512S2024-11-12
00812608022342PMIPMICCXLKT2024-11-12
00812608022304PMIPMICC5122024-11-12
00812608022335PMIPMICC512S2024-11-12
00812608022359PMIPMICCXLKT2024-11-12
00812608021444PMIK411CK411C2016-09-19
00812608020980PMIPMIORCAP20PMIORCAP202016-10-05
00812608020997PMIPMIXLPINPMIXLPIN2016-09-23
00812608021000PMIPMIXL11PMIXL112016-09-23
00812608021017PMIPMIORCBPMIORCB2016-09-23
00812608021024PMIPMILAP13PMILAP132016-09-23
00812608021031PMIPMIPIN152016-09-23
00812608021062PMIPMIORCA2016-09-23
00812608021529PMIPMIORCAP20PMIORCAP202017-08-01
00812608021543PMIPMIXLPINPMIXLPIN2017-08-01
00812608021734PMIPMICATH20PMICATH202018-01-22
00812608020232PMIPMISG10PMISG102016-09-23
00812608020256PMIPMISG12B2PMISG12B22016-09-23
00812608020270PMIPMISG12B4PMISG12B42016-09-23
00812608020119PMIPMI-500PMI-5002016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G079INL1160070Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
G079INL1160120Inlet Bone Fixation SystemIntelivation, LLCFZX2026-04-17
08806373887772BENCOX Surgical InstrumentsCorentec Co., LtdFZX2026-01-12
08800089479375Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2025-12-04
07640332475348CURE 2.0 ACPSpineArt SAFZX2025-11-12
07640375235732PERLA ® TL MISSpineArt SAFZX2025-11-10
G79153202001620G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
G79153202021615G0WishFIXRed Star Contract Manufacturing Inc.FZX2025-10-06
08800071017462Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017479Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017486Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017493Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017509Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017516Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071017523Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084389Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084396Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084402Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084419Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084426Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
08800071084433Surgical InstrumentOSTEONIC CO.,Ltd.FZX2025-06-24
G463090799PK0Spine InstrumentsBOXSPINE HOLDINGS, INC.FZX2025-01-16
08800089436033Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436040Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436057Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436064Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436071Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436088Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436095Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17
08800089436101Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationFZX2023-01-17