FDA.reportPublic FDA data

ELMED

Primary DI
00850011214053
Brand
ELMED
Company
PROGRESSIVE MEDICAL INSTRUMENTATION INC
Model
PMI52-25547A1
Catalog number
PMI52-25547A1
Device description
BLUNT GRASPER D/A 1 PIECE 5MM 32CM
Published
2019-09-06
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
GCJLaparoscope, General & Plastic Surgery

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GCJLaparoscope, General & Plastic SurgeryGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850011214053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011214053008500112140538500112140530850011214053

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
00850011214381ELMEDPMI52-25571A1PMI52-25571A12019-11-15
00850011214398ELMEDPMI52-205100PMI52-2051002019-11-15
00850011214374ELMEDPMI52-00548PMI52-005482019-11-01
00850011214329ELMEDPMI422010PMI4220102019-10-01
00850011214336ELMEDPMI425301PMI4253012019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04048551158913n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04048551158937n.a.Karl Storz GmbH & Co. KGGCJ2026-11-04
04251303804093TrokamedTROKAMED GmbHGCJ2026-11-03
04251303804116TrokamedTROKAMED GmbHGCJ2026-11-03
04251303808916TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809036TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809043TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809050TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809067TrokamedTROKAMED GmbHGCJ2026-11-03
04251303809074TrokamedTROKAMED GmbHGCJ2026-11-03
04251303810933TrokamedTROKAMED GmbHGCJ2026-11-03
04251303817611TrokamedTROKAMED GmbHGCJ2026-11-03
04048551431603n.a.Karl Storz GmbH & Co. KGGCJ2026-11-02
08904332600803MediflexENDOSYS HEALTHCARE INDIA PRIVATE LIMITEDGCJ2026-11-02
B382SD13108150Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD15908450Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD32154290Surgical DirectSurgical Direct, Inc.GCJ2026-10-30
B382SD13517450Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD13518130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD15908130Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
B382SD77505940Surgical DirectSurgical Direct, Inc.GCJ2026-10-28
00190776436827MillenniumAvalign Technologies, Inc.GCJ2026-10-22
B382SD772553050Surgical DirectSurgical Direct, Inc.GCJ2026-10-22
00190776435677MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435684MillenniumAvalign Technologies, Inc.GCJ2026-10-21
00190776435493MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435547MillenniumAvalign Technologies, Inc.GCJ2026-10-20
00190776435295MillenniumAvalign Technologies, Inc.GCJ2026-10-19
00190776435455MillenniumAvalign Technologies, Inc.GCJ2026-10-19
B354OSCVORTH80Tube HolderORANGE SURGICAL INSTRUMENTS, LLCGCJ2026-10-19