FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653154951
Brand
AESCULAP
Company
Aesculap AG
Model
ET005R
Catalog number
ET005R
Device description
DE LEE PELVIMETER GRAD-IN/CM
Published
2020-05-08
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
HERPELVIMETER, EXTERNAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HERPelvimeter, ExternalObstetrics/Gynecology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653154951PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653154951040386531549514038653154951

GMDN Terms#

Term, Definition table
TermDefinition
General-purpose calliper, metallicA manually-operated metallic device with an analogue Vernier scale designed to make accurate measurements of a patient's anatomy, or of other objects, during surgery, autopsy, or in other clinical settings. It is intended to make external measurements (e.g., external diameter, thickness), internal measurements (e.g., internal diameter, depth), measure length, or make step measurements (i.e., from a larger edge to a lesser edge on an object). It is typically made of stainless steel or chrome-plated steel and can be sterilized in a steam sterilizer (an autoclave). This is a reusable device.

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
04038653033997AESCULAPDC230RDC230R2020-06-17
04038653034321AESCULAPDE112RDE112R2020-06-17
04038653034369AESCULAPDE116RDE116R2020-06-17
04038653034376AESCULAPDE117RDE117R2020-06-17
04038653034406AESCULAPDE120RDE120R2020-06-17
04038653034901AESCULAPDE676RDE676R2020-06-17
04046963116194S4 CERVICALFW028UFW028U2020-08-24
04046963794248ELAN 4GA768GA7682020-04-24
04046963935184HI-LINE XXSGE813SUGE813SU2020-04-24
04046963935191HI-LINE XXSGE814SUGE814SU2020-04-24
04046963966362ELAN 4GA767GA7672020-04-24
04046964054907ELAN 4GA715RGA715R2020-04-24
04046964076664AESCULAPGE812SUGE812SU2020-04-24
04046964526213ECCOSGB068RGB068R2020-04-24
04038653013845AESCULAPOP297ROP297R2017-07-31
04038653081141AESCULAPOP913OP9132016-09-23
04038653081158AESCULAPOP914OP9142020-08-10
04038653013852AESCULAPOP298ROP298R2020-04-17
04046963730109AESCULAPOP923OP9232019-04-30
04046955273508AICONJJ612JJ6122022-02-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586OB6421210Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
G586OB6421410Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
G586OB96421410Novo SurgicalNOVO SURGICAL, INC.HER2023-12-18
00842331183676Novo Surgical Inc. NOVO SURGICAL, INC.HER2022-11-14
04038653154975AESCULAPAesculap AGHER2020-05-08
10381780495079Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
10381780495086Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
H8343022300Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
H8343022350Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2018-10-24
10885403046735V. MuellerSTERIS CORPORATIONHER2018-08-30
10381780203056Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
10381780409328Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M274X4133461Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16
M2745101301Integra® Jarit®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHER2017-05-16