FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653168798
Brand
AESCULAP
Company
Aesculap AG
Model
FO216R
Catalog number
FO216R
Device description
"MUEHLING Bone Shears, angled to side, 8 1/4"", (210 mm), serrated (inside), blunt/blunt, double articulated joint, non-sterile, reusable"
Published
2020-04-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRRSCISSORS, ORTHOPEDIC, SURGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRRScissors, Orthopedic, SurgicalOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653168798PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653168798040386531687984038653168798

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose surgical scissors, reusableA non-dedicated, hand-held manual surgical instrument designed to cut a variety of tissues during open surgery; it is not dedicated to surgery at a specific anatomy/body orifice nor does it have a single clinical intended use. It might in addition be intended for cutting sutures or other materials associated with surgery. It is comprised of two pivoted shearing blades with handles, whereby the blades cut as the sharpened edges pass one another as they are closed. It is typically made of metal and is available in various designs and sizes, and some types can have carbide inserts along the cutting edges. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)282-9000GUDID.BBMUS_Service@bbraun.com

Regulatory Flags#

DUNS number
315018218
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
04046964680878COREHIP EXTENDEDNK1126TNK1126T2020-08-10
04046964681028COREHIP EXTENDEDNK1131TNK1131T2020-08-10
04046964681127COREHIP PRIMARYNK1201KNK1201K2020-08-10
04046964681189COREHIP PRIMARYNK1207KNK1207K2020-08-10
04046964681301COREHIP PRIMARYNK1209KNK1209K2020-08-10
04046964681349COREHIP PRIMARYNK1221KNK1221K2020-08-10
04046964681363COREHIP PRIMARYNK1223KNK1223K2020-08-10
04046964681387COREHIP PRIMARYNK1225KNK1225K2020-08-10
04046964681400COREHIP PRIMARYNK1227KNK1227K2020-08-10
04046964681424COREHIP PRIMARYNK1229KNK1229K2020-08-10
04046964681462COREHIP PRIMARYNK1241KNK1241K2020-08-10
04046964681486COREHIP PRIMARYNK1243KNK1243K2020-08-10
04046964681509COREHIP PRIMARYNK1245KNK1245K2020-08-10
04046964681523COREHIP PRIMARYNK1247KNK1247K2020-08-10
04046964681547COREHIP PRIMARYNK1249KNK1249K2020-08-10
04046963929435NOVOCARTFR719RFR719R2020-08-24
04046963933357NOVOCARTFR651RFR651R2020-08-24
04038653289509NOVOCARTFR661RFR661R2020-08-10
04046963565992NOVOCARTFR660SUFR660SU2020-04-24
04046963939588NOVOCARTFR744RFR744R2020-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338005689CuretteELLIQUENCE, LLCHRR2026-06-02
00846338005696CuretteELLIQUENCE, LLCHRR2026-06-02
00846338005702CuretteELLIQUENCE, LLCHRR2026-06-02
08961104622838All Purpose ScissorsMELPEX BEAUTY INSTRUMENTSHRR2026-05-21
08961104622845Crown ScissorsMELPEX BEAUTY INSTRUMENTSHRR2026-05-21
04059453049223Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2026-03-02
00810207783954Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783961Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783978Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
00810207783985Van SickleVAN SICKLE SURGICAL INSTRUMENTS, INCORPORATEDHRR2025-11-24
04059453054517Hermann Medizintechnik GmbHHermann Medizintechnik GmbHHRR2025-08-28
00757770505784Bausch + LombBausch & Lomb IncorporatedHRR2025-08-08
00194613061821MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613096328MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114121MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114671MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613114688MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613115135MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
00194613120092MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-08-01
B35675470110American MedicalsAmerican MedicalsHRR2025-06-30
B35675475110American MedicalsAmerican MedicalsHRR2025-06-25
00194613096311MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613096342MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00194613115142MSI Precision Specialty InstrumentsMed Saver, Inc.HRR2025-03-21
00846338005634Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005641Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005658Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005665Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338005672Bone CuretteELLIQUENCE, LLCHRR2025-01-10
00846338002237Bone CuretteELLIQUENCE, LLCHRR2025-01-09