FDA.reportPublic FDA data

V. Mueller

Primary DI
10885403102493
Brand
V. Mueller
Company
STERIS CORPORATION
Model
OS1512
Catalog number
OS1512
Device description
V. Mueller GERZOG MALLET LEAD FILLED HEAD 1 inches 2.5 CM WEIGHT 10 OZ 280G OVERALL LENGTH 7-1/4 inches 18.6CM
Published
2018-09-10
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
HXLMALLET

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXLMalletGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885403102493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088540310249310885403102493

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. 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
04054462912995evonosevonos GmbH & Co. KGHXL2026-08-19
04054462913008evonosevonos GmbH & Co. KGHXL2026-08-19
04054462913015evonosevonos GmbH & Co. KGHXL2026-08-19
04054462905553evonosevonos GmbH & Co. KGHXL2026-08-18
04054462907618evonosevonos GmbH & Co. KGHXL2026-08-18
04054462907625evonosevonos GmbH & Co. KGHXL2026-08-18
B382SD5422310000Surgical DirectSurgical Direct, Inc.HXL2026-08-03
B382SD914542230Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD9145561200Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD9145571030Surgical DirectSurgical Direct, Inc.HXL2026-07-27
B382SD914569410000Surgical DirectSurgical Direct, Inc.HXL2026-07-27
00817493028257Hive Standalone Cervical SystemNanohive Medical LLCHXL2026-05-08
00840311245635Streamline® MIS Spinal Fixation SystemXtant Medical Holdings, Inc.HXL2026-03-18
00810158218871PRINCETONPrinceton Medical Group, Inc.HXL2026-02-16
B382SD9145561170Surgical DirectSurgical Direct, Inc.HXL2026-02-16
B382SD9141061010Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145561160Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD914556300Surgical DirectSurgical Direct, Inc.HXL2026-02-09
B382SD9145970180Surgical DirectSurgical Direct, Inc.HXL2026-02-09
03662663083683ActivLHighridge Medical, LLCHXL2026-02-03
00840180545829General InstrumentsALPHATEC SPINE, INC.HXL2026-01-29
00810158218482PRINCETONPrinceton Medical Group, Inc.HXL2026-01-15
00841731135322Redemption VILEX LLCHXL2026-01-12
03662663154543SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663154581SOLITAIRE CERVICAL SPACER SYSTEMHighridge Medical, LLCHXL2025-12-29
03662663155601Zyston Interbody Spacer SystemHighridge Medical, LLCHXL2025-12-29
00840194418157PediflexORTHOPEDIATRICS CORP.HXL2025-12-11
03662663217002Telluride MIS Spinal Fixation SystemHighridge Medical, LLCHXL2025-11-17
03662663267199Timberline Lateral Fusion SystemHighridge Medical, LLCHXL2025-11-16
00887868294976TM Ardis Interbody SystemHighridge Medical, LLCHXL2025-11-14