FDA.reportPublic FDA data

AESCULAP

Primary DI
04046955074556
Brand
AESCULAP
Company
Aesculap AG
Model
EO422R
Catalog number
EO422R
Device description
HULKA-KENWICK Uterine Forceps, curved, 10 3/4", (273 mm), non-sterile, reusable
Published
2019-02-18
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
HCZFORCEPS, SURGICAL, GYNECOLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HCZForceps, Surgical, GynecologicalObstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046955074556PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046955074556040469550745564046955074556

GMDN Terms#

Term, Definition table
TermDefinition
Uterine elevatorA hand-held surgical instrument used to lift and manipulate the structure of the uterus to facilitate examination and surgery on this organ and/or the surrounding organs/tissue during a surgical intervention. It is typically a single-ended device with a blunted blade or hook with no cutting edges that can be of various shapes and a handle at the proximal end. It is usually made of high-grade stainless steel. 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
DM exempt
true
Premarket exempt
false
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
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
04038653177035AESCULAPOG963ROG963R2016-09-23
04038653242962AESCULAPDF262RDF262R2020-06-17
04038653339563AESCULAPJG901JG9012025-03-22
04038653345038AESCULAPJG910JG9102020-05-20
04038653038244AESCULAPDP511RDP511R2020-06-17
04038653038251AESCULAPDP512RDP512R2020-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810123209972Adler Instrument CompanyAdler, Inc.HCZ2026-03-03
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00198506085420ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-09-09
00198506085437ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-09-09
00198506082962ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-05-22
00198506017797ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-04-11
00198506082054ELMED INCORPORATEDELMED INCORPORATEDHCZ2025-04-11
00198506066016ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066023ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066078ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506066085ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069758ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069802ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506069819ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-12
00198506065828ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065835ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065842ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506065859ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-11-01
00198506072840ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-28
00198506063077ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506063145ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065453ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065613ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065620ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506065811ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-16
00198506017568ELMED INCORPORATEDELMED INCORPORATEDHCZ2024-10-03
00840343723408GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00840343723699GEN2SURGIX MEDICAL LLCHCZ2024-09-18
00887482077993Symmetry Surgical®SYMMETRY SURGICAL INC.HCZ2024-08-07
00887482040386Symmetry Surgical®SYMMETRY SURGICAL INC.HCZ2024-08-06