FDA.reportPublic FDA data

AESCULAP

Primary DI
04038653176373
Brand
AESCULAP
Company
Aesculap AG
Model
OF608R
Catalog number
OF608R
Device description
POLITZER TYMPANUM PERFORATOR ANG160MM
Published
2020-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KATPERFORATOR, ANTRUM

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KATPerforator, AntrumEar, Nose, Throat1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04038653176373PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04038653176373040386531763734038653176373

GMDN Terms#

Term, Definition table
TermDefinition
Suturing needle, reusableA non-sterile, cylindrical-shaped, solid, metal instrument intended to be used to insert and pull suture material through tissue (e.g., skin, fascia, serous, vascular, or other tissue/organ) during surgical stitching of tissues. It is available in various lengths, curvatures, diameters, cross-sectional shapes, and distal end forms; included is the Reverdin type needle with an eye that can be opened and closed with a sliding mechanism on a handle intended to facilitate ease of suturing. 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
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
04038653051472AESCULAPAesculap AGKAT2020-05-20
04046964073090AESCULAPAesculap AGKAT2020-04-24
04046964073205AESCULAPAesculap AGKAT2020-04-24
04046964073212AESCULAPAesculap AGKAT2020-04-24
04046964073229AESCULAPAesculap AGKAT2020-04-24
04046964073236AESCULAPAesculap AGKAT2020-04-24
04046964073243AESCULAPAesculap AGKAT2020-04-24
04038653207251AESCULAPAesculap AGKAT2020-04-23
04038653176458AESCULAPAesculap AGKAT2020-04-22
04038653176465AESCULAPAesculap AGKAT2020-04-22
04038653176472AESCULAPAesculap AGKAT2020-04-22
10885403114366V. MuellerCAREFUSION 2200, INCKAT2020-04-15
10885403114335V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114427V. MuellerSTERIS CORPORATIONKAT2018-09-10
10885403114328V. MuellerSTERIS CORPORATIONKAT2018-09-10
00841036021511N/ABIOMET MICROFIXATION, INCKAT2017-06-16