FDA.reportPublic FDA data

NA

Primary DI
00845384000952
Brand
NA
Company
Anspach Effort, The
Model
BLA-2
Catalog number
BLA-2
Device description
2.15 mm x 25.4 mm Fluted Router. Use with B-BLACK Attachment.
Published
2016-09-09
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K974025000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974025000ANSPACH SHIELDED ATTACHMENTThe Anspach Effort, Inc.1998-07-06GFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384000952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384000952008453840009528453840009520845384000952

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00845384018759EG1™WIRELESS-HCWIRELESS-HC2022-07-08
00845384018766EG1™RECEIVER-HCRECEIVER-HC2022-07-08
00845384014249NAL-5B-A-G1L-5B-A-G12016-09-09
00845384012269NAHK-2100-02-FPHK-2100-02-FP2016-10-17
00845384012290NAAL-9152-00-FPAL-9152-00-FP2016-10-17
00845384002536NAHOSE-20-DISSHOSE-20-DISS2016-10-17
00845384005599NAMUFFLER-ASSYMUFFLER-ASSY2016-10-17
00845384010784NAXM-CASEXM-CASE2018-02-05
00845384010791NAXMAXXMAX2018-02-05
00845384012276NA16-3100-FP16-3100-FP2016-09-09
00845384012313NAHE-4005-10-FPHE-4005-10-FP2016-09-09
00845384012320NA45-0432-FP45-0432-FP2016-09-09
00845384016595NAE-HCE-HC2018-02-05
00845384006343NAQD11-8NDQD11-8ND2016-09-09
00845384016588NAMIA16-5DRMMIA16-5DRM2016-09-09
00845384000396NAAUTOLUBE-IIIAUTOLUBE-III2016-10-17
00845384000402NAAUTOLUBE-III-20AUTOLUBE-III-202016-10-17
00845384000457NAAUTOLUBE-III-IRRAUTOLUBE-III-IRR2016-10-17
00845384000464NAAUTOLUBE-III-MA7AUTOLUBE-III-MA72016-10-17
00845384001676NACDACDA2018-02-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817438028762N/AOmega Surgical Instruments IncGFF2026-10-05
14053613298343KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613298350KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-30
14053613293133KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2026-09-25
05051471225985De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGFF2026-08-01
00817438028724N/AOmega Surgical Instruments IncGFF2026-07-24
00817438028755N/AOmega Surgical Instruments IncGFF2026-07-21
10080196377244MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
10080196385560MEDLINEMEDLINE INDUSTRIES, INC.GFF2025-01-29
14053613053232KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613054222KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613167298KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613205525KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613266892KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268599KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268612KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613268650KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021289G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226021291G11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226031156AU1KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226017146A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
E226046554A11KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-02-01
14053613001493KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001738KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613001998KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613002322KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613266915KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613267578KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613272435KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31
14053613273418KOMET Surgical BurGebr. Brasseler GmbH & Co. KGGFF2023-01-31