FDA.report

Medline

Primary DI
20888277374147
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
4448R
Catalog number
4448R
Device description
4448 @ECTRA II, TRIANGLE KNIFE, (GREEN)
Published
2022-05-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
NBHAccessories, arthroscopic

Product Code Classifications

CodeDeviceSpecialtyClass
NBHAccessories, ArthroscopicOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20888277374147PackageGS16In Commercial Distribution
10888277374140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
2088827737414720888277374147
1088827737414010888277374140

GMDN Terms

TermDefinition
Carpal tunnel release instrumentA sterile, hand-held, manual, surgical instrument designed for percutaneous or mini-open transection of the transverse carpal ligament for median nerve decompression. It typically consists of a tubular fenestrated probe that contains a wire with a toothed cutting segment, attached to a handle with a lever to extend and retract the wire. The probe is inserted through the carpal tunnel and the wire extended to expose the cutting section through the probe window, and distally through the skin so that it can be gripped to enable a manual sawing motion to transect the ligament. The probe may include a conductor for connecting to an external nerve-locating system. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
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
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417918MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776417949MillenniumAvalign Technologies, Inc.NBH2026-03-23
00190776418267MillenniumAvalign Technologies, Inc.NBH2026-03-23
B382SD18129DK0Surgical DirectSurgical Direct, Inc.NBH2026-03-09
B382SD316590Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD316790Surgical DirectSurgical Direct, Inc.NBH2026-02-26
B382SD9156321000Surgical DirectSurgical Direct, Inc.NBH2026-02-26
00190776416386MillenniumAvalign Technologies, Inc.NBH2026-02-16
04055207068243VERTEBRISRichard Wolf GmbHNBH2026-02-10
04055207069691NARichard Wolf GmbHNBH2026-02-10
04055207069707NARichard Wolf GmbHNBH2026-02-10
04055207069714NARichard Wolf GmbHNBH2026-02-10
04055207069721NARichard Wolf GmbHNBH2026-02-10
04055207069738NARichard Wolf GmbHNBH2026-02-10
04055207069745NARichard Wolf GmbHNBH2026-02-10
B382SD181290Surgical DirectSurgical Direct, Inc.NBH2026-02-06
10748426142719Arthrex®Microtek Medical LLCNBH2026-02-02
07630542726620SportMeds InstrumentsMedacta International SANBH2026-01-30
00888867516144Arthrex®ARTHREX, INC.NBH2026-01-28
00888867516168Arthrex®ARTHREX, INC.NBH2026-01-28
07630542703683SportMeds InstrumentsMedacta International SANBH2026-01-21
00812231034170ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00812231034941ZEOSSANTA BARBARA IMAGING SYSTEMS, INC.NBH2026-01-19
00198506087622ELMED INCORPORATEDELMED INCORPORATEDNBH2026-01-16
04055207069790NARichard Wolf GmbHNBH2026-01-14
04055207069806NARichard Wolf GmbHNBH2026-01-14
04055207069813NARichard Wolf GmbHNBH2026-01-14
04055207069820NARichard Wolf GmbHNBH2026-01-14
04055207069837NARichard Wolf GmbHNBH2026-01-14
04055207069851NARichard Wolf GmbHNBH2026-01-14