FDA.reportPublic FDA data

Disposable Blade Assembly

Primary DI
00861994000281
Brand
Disposable Blade Assembly
Company
Hand Biomechanics Lab Inc
Model
CTR-455
Catalog number
CTR-455
Device description
Endoscopic Carpal Tunnel Release Disposable Blade Assembly
Published
2021-12-06
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMFKnife, Surgical
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMFKnife, SurgicalGeneral, Plastic Surgery1
HRXArthroscopeOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222490000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222490000HBL Blade AssemblyHand Biomechanics Lab, Inc.2022-11-14HRX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10861994000288PrimaryGS10
00861994000281Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086199400028810861994000288
00861994000281008619940002818619940002810861994000281

GMDN Terms#

Term, Definition table
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 table
Method

Contacts#

Phone, Email table
PhoneEmail
916-923-5073info@handbiolab.com

Regulatory Flags#

DUNS number
620754127
Device count
6
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00861994000205Agee WristJack®CFD-1472015-10-23
00861994000212Agee Digit Widget®DWD-2322015-10-23
00861994000229Agee TurnKey FCS®FCS-4002015-10-23
00861994000236Agee WristJack® RemanufacturedCFD-147-RNSCFD-147-R2015-10-23
00861994000243PIP FixPFX-426PFX-4262019-02-20
10861994000288Disposable Blade AssemblyCTR-455CTR-4552021-12-06

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