FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403067013
Brand
V. Mueller
Company
CAREFUSION 2200, INC
Model
MO9655
Catalog number
MO9655
Device description
SMITH SAGITTAL-TYPE SPLIT SEPARATOR 9MM X 10MM WIDE, CURVED LEFT OVERALL LENGTH 7" (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
OTC
false
Sterile
false
Single use
false

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
10885403067013PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540306701310885403067013

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
832696038
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50382909101206Surgiphor9101209101202026-03-05
10885403273780PleurX50-007550-00752017-06-12
10885403075964PleurX50-905050-90502017-06-12
50885403075993Denver42-200042-20002017-06-12
50885403076006Denver42-205542-20552017-06-12
50885403076082Denver42-205042-20502017-06-12
10885403051722V. MuellerHY21305HY213052017-08-11
10885403049408V. MuellerGU4050-008GU4050-0082018-08-30
10885403071263V. MuellerNL1350NL13502018-09-05
10885403105159V. MuellerOS5000-002OS5000-0022018-09-10
20885403473170N/A5513E5513E2019-03-25
50885403142176Wet Exidine448944892018-07-18
50885403142183NA442044202018-07-18
50885403142190NA4461A4461A2018-07-18
50885403142220NA4472A4472A2018-07-18
50885403175211NA443744372018-07-18
50885403184473NA446844682018-07-18
50885403184480NA4469A4469A2018-07-18
50885403192829Scrub Care ExidineCLEAN1CLEAN12018-05-02
10885403465154Snowden-PencerSI325SI3252018-01-16

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Primary DI, Brand, Company table
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07899798208858QuinelatoSchobell Industrial LtdaKAL2025-02-27
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00757770402526Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
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00757770419371Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770419463Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420407Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21
00757770420421Bausch + LombBausch & Lomb IncorporatedKAL2024-11-21