FDA.reportPublic FDA data

Clip Remover

Primary DI
00810607000453
Brand
Clip Remover
Company
ACRA-CUT INC
Model
500-135
Catalog number
500-135
Device description
Clip Remover Catalog#500-135
Published
2017-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBQInstrument, Clip Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBQInstrument, Clip RemovalNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810607000453PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810607000453008106070004538106070004530810607000453

GMDN Terms#

Term, Definition table
TermDefinition
Scalp clip applier, reusableA hand-held, manually-operated, surgical instrument used for the application (the attachment) of nonimplantable, single-use scalp clips to the margins of a scalp wound/incision during a surgical intervention on the cranium/scalp. Often referred to as a clip gun, it has a pistol-like design and holds an exchangeable, preloaded cassette of scalp clips that are fired into the scalp tissue, with the pull of a trigger, to approximate the margins of the wound/incision until it heals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
9782632210info@acracut.com

Regulatory Flags#

DUNS number
612611459
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810607000224Distraction Screws Caspar type800-499800-4992017-05-01
00810607000231Distraction Screws Caspar type800-499x800-499x2017-05-01
00810607000248Distraction Screw Caspar type800-500800-5002017-05-01
00810607000255Distraction Screws Caspar type800-500x800-500x2017-05-01
00810607000262Distraction Screws Caspar type800-501800-5012017-05-01
00810607000279Distraction Screws Caspar type800-501x800-501x2017-05-01
00810607000286Distraction Screws Caspar type800-502800-5022017-05-01
00810607000293Distraction Screws Caspar type800-502x800-502x2017-05-01
00810607002006ACRA-CUT14/9mm SDR (SMARTdrill)200-5002016-09-23
00810607002211ACRA-CUT14/11mm CDM210-2212016-09-23
00810607002310ACRA-CUT11/7mm DG-II mini200-3312016-09-23
00810607002419ACRA-CUT14/11mm DGR-I200-2412016-09-23
00810607002433ACRA-CUT11/7mm DR-I mini200-2432016-09-23
00810607002518ACRA-CUT14/11mm DGR-II200-2512017-01-17
00810607002532ACRA-CUT11/7mm DGR-II Mini200-2532016-09-23
00810607002556ACRA-CUT13/9mm DGR-II200-2552017-01-17
00810607002716ACRA-CUT14/11mm DGR-O200-2712016-09-23
00810607002754ACRA-CUT13/9mm DGR-O200-2752016-09-23
00810607002839ACRA-CUT8/5mm DGR-OS mini Stereotactic200-2832016-09-23
00810607000019Disposable Cranial Perforator200-241 14/11mm200-241 DGR-I2017-05-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04038653170036AESCULAPAesculap AGHBQ2020-08-10
00840096207583Khaimi Concentrator, Smooth, 0.45KATALYST SURGICAL LLCHBQ2020-06-08
04038653170005AESCULAPAesculap AGHBQ2020-04-22
04038653170012AESCULAPAesculap AGHBQ2020-04-22
04038653170029AESCULAPAesculap AGHBQ2020-04-22
00840096203660Khaimi Concentrator, 0.25 mLKATALYST SURGICAL LLCHBQ2019-07-02
00840096203684Khaimi Concentrator, 0.33 mLKATALYST SURGICAL LLCHBQ2019-07-02
00840096203691Khaimi Concentrator, 0.35 mLKATALYST SURGICAL LLCHBQ2019-07-02
00857987006187Vitalitec Clip RemoversVITALITEC INTERNATIONAL, INC.HBQ2018-12-13
00857987006194Vitalitec Clip RemoversVITALITEC INTERNATIONAL, INC.HBQ2018-12-13
24026704508758PILLINGTELEFLEX INCORPORATEDHBQ2018-09-15
10884521057616Lapro-ClipCovidien LPHBQ2018-08-10