FDA.reportPublic FDA data

ELMED

Primary DI
00850011214381
Brand
ELMED
Company
PROGRESSIVE MEDICAL INSTRUMENTATION INC
Model
PMI52-25571A1
Catalog number
PMI52-25571A1
Device description
HOOK BIOPSY PUNCH, 32CM 5MM
Published
2019-11-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEIElectrosurgical, Cutting & Coagulation & Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011214381PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011214381008500112143818500112143810850011214381

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
5022671100ORDERS@PMIREPAIRS.COM

Regulatory Flags#

DUNS number
131054074
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850011214442ELMEDPMI23-40045STRPMI23-40045STR2019-12-06
00850011214404AVALIGNPMI-HD-SPMI-HD-S2019-11-20
00850011214411AVALIGNPMI-B-2VPMI-B-2V2019-11-20
00850011214428AVALIGNPMI-B-3VPMI-B-3V2019-11-20
00850011214435AVALIGNPMI-ABB-11VPMI-ABB-11V2019-11-20
00850011214299AVALIGNPMI-ABB-33VPMI-ABB-33V2019-09-20
00850011214282AVALIGNPMI-ABB-22VPMI-ABB-22V2019-09-18
00850011214077AVALIGNPMI-RD-DPMI-RD-D2019-09-06
00850011214084AVALIGNPMI-HD-DPMI-HD-D2019-09-06
00850011214091AVALIGNPMI-DC-1-BPMI-DC-1-B2019-09-06
00850011214107AVALIGNPMI-B3-VBPMI-B3-VB2019-09-06
00850011214497ELMEDPMI37-500707PMI37-5007072020-02-18
00850011214473ELMEDPMI59-8010BMPMI59-8010BM2020-01-03
00850011214459ELMEDPMI52-25560B1PMI52-25560B12019-12-23
00850011214466ELMEDPMI52-25566B1PMI52-25566B12019-12-23
00850011214398ELMEDPMI52-205100PMI52-2051002019-11-15
00850011214374ELMEDPMI52-00548PMI52-005482019-11-01
00850011214329ELMEDPMI422010PMI4220102019-10-01
00850011214336ELMEDPMI425301PMI4253012019-10-01
00850011214343ELMEDPMI403658PMI4036582019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00198506091292ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091308ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091360ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091377ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091384ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00198506091391ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-09
00860015792006NOVOCLEAR™ DeviceAventix Medical Inc.GEI2026-06-09
00860015792013AVENTIX® PFX SystemAventix Medical Inc.GEI2026-06-09
00685447020677RFP-100A™ RF Puncture GeneratorBOSTON SCIENTIFIC CORPORATIONGEI2026-06-08
08800042706159Artisential Monopolar SpatulaLIVSMEDGEI2026-06-05
00840319759042Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759059Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759066Hayden MedicalHayden Medical, Inc.GEI2026-06-04
00840319759073Hayden MedicalHayden Medical, Inc.GEI2026-06-04
08809306764072VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764089VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764133VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764140VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764157VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764164VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764171VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
08809306764188VIVA RF ElectrodeSTARMED CO.,LTDGEI2026-06-04
00198506091261ELMED INCORPORATEDELMED INCORPORATEDGEI2026-06-03
00846338001209IEC BiPolar Cable, DisposableELLIQUENCE, LLCGEI2026-06-03
00846338001230Bipolar CableELLIQUENCE, LLCGEI2026-06-03
00846338001247Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001537Bipolar Cable - 2 Flat ProngsELLIQUENCE, LLCGEI2026-06-03
00846338001582IEC Power Cord 110vELLIQUENCE, LLCGEI2026-06-03
00846338001605IEC Power Cord 220v ANZ PlugELLIQUENCE, LLCGEI2026-06-03
00846338001612IEC Power Cord 220v EuropeELLIQUENCE, LLCGEI2026-06-03