FDA.reportPublic FDA data

PMI

Primary DI
00812608020232
Brand
PMI
Company
PROGRESSIVE MEDICAL, INC.
Model
PMISG10
Catalog number
PMISG10
Device description
PMI Suture Guide (10/12mm) - Reusable
Published
2016-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
10812608020239PackageGS14In Commercial Distribution
00812608020232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081260802023910812608020239
00812608020232008126080202328126080202320812608020232

GMDN Terms#

Term, Definition table
TermDefinition
Needle guide, reusableA non-powered device designed to direct a sharp needle (not included) 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
"[""Ethylene Oxide"", ""Moist Heat or Steam Sterilization""]"

Contacts#

Phone, Email table
PhoneEmail
314-961-5786CS@PROGRESSIVEMEDINC.COM

Regulatory Flags#

DUNS number
192135242
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
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
00812608020256PMIPMISG12B2PMISG12B22016-09-23
00812608020270PMIPMISG12B4PMISG12B42016-09-23
00812608020119PMIPMI-500PMI-5002016-09-23
00812608020126PMIPMI-10PMI-102016-09-23

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10886982363015NASynthes GmbHFZX2026-08-26
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00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
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