FDA.reportPublic FDA data

NA

Primary DI
00845384009702
Brand
NA
Company
Anspach Effort, The
Model
TURQ-5
Catalog number
TURQ-5
Device description
5 mm Fluted Ball. Use with B-TURQUOISE Attachment.
Published
2016-09-09
Public version status
Update
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
GFFBUR, SURGICAL, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GFFBur, Surgical, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384009702PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384009702008453840097028453840097020845384009702

GMDN Terms#

Term, Definition table
TermDefinition
Cranial bur, single-useA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal and/or diamond material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate soft or hard skull tissue. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500RA-DPYNA-anspachpowe@its.jnj.com

Regulatory Flags#

DUNS number
079116867
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
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
00845384018759EG1™WIRELESS-HCWIRELESS-HC2022-07-08
00845384018766EG1™RECEIVER-HCRECEIVER-HC2022-07-08
00845384016526EG1™ High Speed SystemXL-HD-G1XL-HD-G12021-05-05
00845384018520KINCISE™1000-00-1011000-00-1012020-04-28
00845384018537KINCISE™1002-00-1021002-00-1022020-04-28
00845384018544KINCISE™1003-00-1011003-00-1012020-04-28
00845384018551KINCISE™1010-01-1011010-01-1012020-04-28
00845384018568KINCISE™1010-01-1021010-01-1022020-04-28
00845384018575KINCISE™1011-01-1011011-01-1012020-04-28
00845384018582KINCISE™1012-01-1011012-01-1012020-04-28
00845384018612KINCISE™1013-00-1011013-00-1012020-04-28
00845384018629KINCISE™1013-00-9011013-00-9012020-04-28
00845384017790Anspach HelixS-2SB-HX-G1S-2SB-HX-G12019-12-11
00845384017806Anspach HelixS-2B-HX-G1S-2B-HX-G12019-12-11
00845384017813Anspach HelixS-25SB-HX-G1S-25SB-HX-G12019-12-11
00845384017820Anspach Helix™S-25B-HX-G1S-25B-HX-G12019-12-11
00845384017837Anspach Helix™S-3SB-HX-G1S-3SB-HX-G12019-12-11
00845384017844Anspach Helix™S-3B-HX-G1S-3B-HX-G12019-12-11
00845384017851Anspach Helix™S-35SB-HX-G1S-35SB-HX-G12019-12-11
00845384017868Anspach Helix™S-35B-HX-G1S-35B-HX-G12019-12-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24053613296209Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-20
07613327687637N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687644N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687651N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687668N/ASTRYKER CORPORATIONGFF2026-03-19
07613327687675N/ASTRYKER CORPORATIONGFF2026-03-19
24053613295929Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613295936Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296131Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296193Bur, tapered, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613296803Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297121Bur, cylindrical, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297190Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297206Bur, Egg / egg shaped, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
24053613297220Bur, Round, round shankGebr. Brasseler GmbH & Co. KGGFF2026-03-11
10888867516950Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517926Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517933Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517940Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517957Arthrex®ARTHREX, INC.GFF2026-03-03
10888867517964Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544052Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544069Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544076Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544083Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544090Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544106Arthrex®ARTHREX, INC.GFF2026-03-03
10888867544120Arthrex®ARTHREX, INC.GFF2026-03-03
04027497285884GT PODO 0.276 in (7 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-11
04027497285822GT PODO 0.394 in (10 mm) round Shank 3/32"LUKAS-ERZETT GmbH & Co. KGGFF2026-02-10