FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403067006
Brand
V. Mueller
Company
STERIS CORPORATION
Model
MO9650
Catalog number
MO9650
Device description
V. Mueller SMITH SAGITTAL-TYPE SPLIT SEPARATOR 9MM X 10MM WIDE, CURVED RIGHT OVERALL LENGTH 7 inches 17.8CM
Published
2018-09-05
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
KALRETRACTOR, ENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KALRetractor, EntEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403067006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540306700610885403067006

GMDN Terms#

Term, Definition table
TermDefinition
Maxillofacial bone separatorA hand-held, manual, one-piece surgical instrument intended to split/force apart bones in the face, mouth and/or jaws (e.g., palate, mandibular inferior border) during maxillofacial surgery (e.g., sagittal split osteotomy procedure); it is not designed to cut or shape bone (i.e., not an osteotome). It is a metal instrument typically available as: 1) a curved shaft with a handle and a blade at the distal working end; or 2) a hinged device with two blades at the distal working end and a spring handle. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)323-9088Customer_Support@BD.com
+1(800)548-4873xx@xx.xx

Regulatory Flags#

DUNS number
021599373
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
00724995237059V. MuellerCD75CCD75C2026-09-24
00724995237066V. MuellerCD75CBLACKCD75CBLACK2026-09-24
00724995237073V. MuellerCD75CBLUECD75CBLUE2026-09-24
00724995237080V. MuellerCD75CGOLDCD75CGOLD2026-09-24
00724995237097V. MuellerCD75CGREENCD75CGREEN2026-09-24
00724995237103V. MuellerCD75CPURPLECD75CPURPLE2026-09-24
00724995237110V. MuellerCD75CREDCD75CRED2026-09-24
00724995237127V. MuellerCD76BCD76B2026-09-24
00724995237134V. MuellerCD76BBLACKCD76BBLACK2026-09-24
00724995237141V. MuellerCD76BBLUECD76BBLUE2026-09-24
00724995237158V. MuellerCD76BGOLDCD76BGOLD2026-09-24
00724995237165V. MuellerCD76BGREENCD76BGREEN2026-09-24
00724995237172V. MuellerCD76BPURPLECD76BPURPLE2026-09-24
00724995237189V. MuellerCD76BREDCD76BRED2026-09-24
00724995237196V. MuellerCD76CCD76C2026-09-24
00724995237202V. MuellerCD76CBLACKCD76CBLACK2026-09-24
00724995237219V. MuellerCD76CBLUECD76CBLUE2026-09-24
00724995237226V. MuellerCD76CGOLDCD76CGOLD2026-09-24
00724995237233V. MuellerCD76CGREENCD76CGREEN2026-09-24
00724995237240V. MuellerCD76CPURPLECD76CPURPLE2026-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995327408V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00724995327422V. MuellerSTERIS Deutschland GmbHKAL2026-09-25
00841536148602ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148619ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148626ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00841536148633ThompsonThompson Surgical Instruments, Inc.KAL2026-09-20
00190776429065MillenniumAvalign Technologies, Inc.KAL2026-09-04
04054462156498evonosevonos GmbH & Co. KGKAL2026-08-26
04054462156504evonosevonos GmbH & Co. KGKAL2026-08-26
04054462913039evonosevonos GmbH & Co. KGKAL2026-08-26
00190776417253MillenniumAvalign Technologies, Inc.KAL2026-08-19
00190776417710MillenniumAvalign Technologies, Inc.KAL2026-08-19
04054462913060evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913077evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913091evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913107evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913114evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913121evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913138evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913145evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913169evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913213evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913237evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913251evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913275evonosevonos GmbH & Co. KGKAL2026-08-19
04054462913152evonosevonos GmbH & Co. KGKAL2026-08-18
04054462915828evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915835evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915842evonosevonos GmbH & Co. KGKAL2026-08-17
04054462915859evonosevonos GmbH & Co. KGKAL2026-08-17