FDA.reportPublic FDA data

NA

Primary DI
00845384004325
Brand
NA
Company
Synthes GmbH
Model
MA-15C
Catalog number
MA-15C
Device description
Bearing Sleeve, 15cm Curved. Use with Minimal Access Attachments.
Published
2018-02-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HBEDRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)Neurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042783000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042783000ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEMThe Anspach Effort, Inc.2004-12-17HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00845384004325PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00845384004325008453840043258453840043250845384004325

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982113078NA04.130.260S04130260S2016-03-15
10886982077868NA03.311.010033110102015-09-14
10886982077875NA03.311.011033110112015-09-14
10886982077882NA03.311.012033110122015-09-14
10886982077899NA03.311.013033110132015-09-14
10886982078131NA03.311.058033110582015-09-14
10886982078148NA03.311.059033110592015-09-14
10886982078155NA03.311.060033110602015-09-14
10886982078186NA03.311.062033110622015-09-14
10886982078193NA03.311.070033110702015-09-14
10886982078209NA03.311.071033110712015-09-14
10886982078247NA03.311.090033110902015-09-14
10886982078254NA03.311.091033110912015-09-14
10886982078261NA03.311.092033110922015-09-14
10886982078438NA03.311.201033112012015-09-14
10886982078445NA03.311.202033112022015-09-14
10886982078452NA03.311.203033112032015-09-14
10886982078469NA03.311.204033112042015-09-14
10886982078476NA03.311.205033112052015-09-14
10886982078520NA03.311.220033112202015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816589021615Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
00816589021622Brasseler Twist DrillbitMONTERIS MEDICAL INCHBE2026-07-03
04589551366217P300-2A100NAKANISHI INC.HBE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HBE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HBE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HBE2026-06-26
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBE2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBE2025-03-21
07630055508072PM2-S MISBien-Air Surgery SAHBE2025-03-21
07630055508065PM2-A MISBien-Air Surgery SAHBE2025-03-20
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBE2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBE2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBE2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBE2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAHBE2023-02-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505811Cranio Guard 10mm rotatingBien-Air Surgery SAHBE2023-02-10
07630055505835Cranio Guard 25mm fixBien-Air Surgery SAHBE2023-02-10
07630055505842RAPIDO MicromotorBien-Air Surgery SAHBE2023-02-10
07630055505866Cranio Guard 10mm fixBien-Air Surgery SAHBE2023-02-10
07630055505873Cranio Guard 15mm fixBien-Air Surgery SAHBE2023-02-10
07630055505910PM2-S125Bien-Air Surgery SAHBE2023-02-10
07630055505927PM2-S150Bien-Air Surgery SAHBE2023-02-10
07630055505675PM2-A70Bien-Air Surgery SAHBE2023-02-09
07630055505682PM2-A150Bien-Air Surgery SAHBE2023-02-09