FDA.reportPublic FDA data

ELMED

Primary DI
00850011214473
Brand
ELMED
Company
PROGRESSIVE MEDICAL INSTRUMENTATION INC
Model
PMI59-8010BM
Catalog number
PMI59-8010BM
Device description
"BIPOLAR FCP RHOTON BAYO 10.75"" INSULATED STRAIGHT 1.3MM"
Published
2020-01-03
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
00850011214473PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850011214473008500112144738500112144730850011214473

GMDN Terms#

Term, Definition table
TermDefinition
Endoscopic electrosurgical handpiece/electrode, bipolar, reusableAn electrosurgical device which consists of a handpiece with mechanical and/or electrical controls, and a bipolar electrode intended to deliver electrosurgical current from a system generator directly to tissues for cutting/coagulation/ablation during endoscopic (including laparoscopic, arthroscopic) surgery; it may in addition be intended for open surgery. It includes a long thin electrode connected to the handpiece, and may include a lumen for suction/irrigation; it is available in a variety of forms (e.g., forceps, rigid probe with controls). 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
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
00850011214343ELMEDPMI403658PMI4036582019-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776426675MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426729MillenniumAvalign Technologies, Inc.GEI2026-08-19
00190776426781MillenniumAvalign Technologies, Inc.GEI2026-08-19
00841019123713KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123720KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123737KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019123744KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00841019124154KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-19
00190776414733MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776415310MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425890MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425913MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425920MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425937MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425944MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776425951MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426354MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426385MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426422MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426545MillenniumAvalign Technologies, Inc.GEI2026-08-18
00190776426552MillenniumAvalign Technologies, Inc.GEI2026-08-18
00198506093982ELMED INCORPORATEDELMED INCORPORATEDGEI2026-08-18
00841019123898KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-18
00840113234356BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237705BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
10840113237712BovieASPEN SURGICAL PRODUCTS, INC.GEI2026-08-17
00190776424527MillenniumAvalign Technologies, Inc.GEI2026-08-07
00841019123935KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
00841019123942KirwanKIRWAN SURGICAL PRODUCTS LLCGEI2026-08-07
07613327548235NeptuneSTRYKER CORPORATIONGEI2026-08-07