FDA.reportPublic FDA data

NA

Primary DI
00845384001232
Brand
NA
Company
Anspach Effort, The
Model
BLU-17-6
Catalog number
BLU-17-6
Device description
6 mm Diamond Ball. Use with B-BLUE-S Attachment.
Published
2016-10-17
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
HSZINSTRUMENT, SURGICAL, ORTHOPEDIC, PNEUMATIC POWERED & ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSZInstrument, Surgical, Orthopedic, Pneumatic Powered & Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384001232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384001232008453840012328453840012320845384001232

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
00887919964308Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971733Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971764Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00887919971795Brasseler USAPeter Brasseler Holdings, LLCHSZ2024-11-19
00763000714635MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
00763000865627MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2023-12-01
08800017288376LOSPA IS Spinal SystemCorentec Co., LtdHSZ2022-10-21
10885862090454AcudriverExactech, Inc.HSZ2022-09-19
10885862090560NAExactech, Inc.HSZ2022-09-19
00847399004338MicroAire® Microaire Surgical Instruments LLCHSZ2022-09-17
00847399004765MicroAire® Microaire Surgical Instruments LLCHSZ2022-09-01
10885862090225NAExactech, Inc.HSZ2022-07-28
10885862090232NAExactech, Inc.HSZ2022-07-28
10885862090256NAExactech, Inc.HSZ2022-07-28
10885862090263NAExactech, Inc.HSZ2022-07-28
10885862090362NAExactech, Inc.HSZ2022-07-28
10885862090379NAExactech, Inc.HSZ2022-07-28
10885862090416NAExactech, Inc.HSZ2022-07-28
10885862090423NAExactech, Inc.HSZ2022-07-28
10885862090430NAExactech, Inc.HSZ2022-07-28
10885862090485NAExactech, Inc.HSZ2022-07-28
10885862090492NAExactech, Inc.HSZ2022-07-28
10885862090508NAExactech, Inc.HSZ2022-07-28
10885862090522NAExactech, Inc.HSZ2022-07-28
10885862090539NAExactech, Inc.HSZ2022-07-28
10885862090546NAExactech, Inc.HSZ2022-07-28
00763000513443MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
00763000513450MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-06-30
00763000513832MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22
00763000513863MIDAS REX MR8MEDTRONIC POWERED SURGICAL SOLUTIONSHSZ2022-04-22