FDA.reportPublic FDA data

AESCULAP

Primary DI
04046964686726
Brand
AESCULAP
Company
AESCULAP, INC.
Model
MF971
Catalog number
MF971
Device description
JAW INSERT F/CLASSIC BIP TUBAL FCP32CM
Published
2016-09-23
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
HETLAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HETLaparoscope, Gynecologic (And Accessories)Obstetrics/Gynecology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04046964686726PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04046964686726040469646867264046964686726

GMDN Terms#

Term, Definition table
TermDefinition
Rigid optical laparoscopeAn endoscope with a rigid inserted portionangulus iridocornealis for the visual examination and treatment of the abdominal/retroperitoneal cavity and its organs. It is inserted through an incision made in the abdominal wall (routinely just below the umbilicus) during laparoscopy. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. The abdominal wall is distended, typically using a gas, providing the space to allow the surgeon to view and/or operate on the exposed organs. This reusable device is commonly used to evaluate/treat abdominal or pelvic pain, ectopic pregnancy, ovarian cysts, appendicitis, and perform female sterilization.

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
082594540
Device count
1
DM exempt
true
Premarket exempt
true
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
04046964993312AESCULAPMG223RMG223R2026-01-16
04046964993329AESCULAPMG224RMG224R2026-01-16
04046955741212AESCULAPFK900NBFK900NB2025-08-17
04046955741229AESCULAPFK901NBFK901NB2025-08-17
04046955741236AESCULAPFK902NBFK902NB2025-08-17
04046955741243AESCULAPFK903NBFK903NB2025-08-17
04046955741250AESCULAPFK904NBFK904NB2025-08-17
04046955741267AESCULAPFK906NBFK906NB2025-08-17
04046955741274AESCULAPFK907NBFK907NB2025-08-17
04046955741281AESCULAPFK908NBFK908NB2025-08-17
04046955741298AESCULAPFK909NBFK909NB2025-08-17
04046955741304AESCULAPFK910NBFK910NB2025-08-17
04046955741311AESCULAPFK960NBFK960NB2025-08-17
04046955741328AESCULAPFK913NBFK913NB2025-08-17
04046955741335AESCULAPFK914NBFK914NB2025-08-17
04046955741342AESCULAPFK915NBFK915NB2025-08-17
04046955741359AESCULAPFK916NBFK916NB2025-08-17
04046955741366AESCULAPFK917NBFK917NB2025-08-17
04046955741373AESCULAPFK961NBFK961NB2025-08-17
04046955741380AESCULAPFK962NBFK962NB2025-08-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972304750407DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
06972304750414DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750381DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750398DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750428DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
16972304750435DeepEyeSurgnova Healthcare Technologies (Zhejiang) Co., Ltd.HET2026-05-22
04251303822769BLUEENDOTROKAMED GmbHHET2026-03-03
04251303824961BLUEENDOTROKAMED GmbHHET2026-02-27
04251303824978BLUEENDOTROKAMED GmbHHET2026-02-27
00817401029130EndoplusEndoplusHET2026-02-06
00817401029123EndoplusEndoplusHET2026-01-16
00817401029116EndoplusEndoplusHET2025-12-19
00198506086892ELMED INCORPORATEDELMED INCORPORATEDHET2025-11-25
G465FG16000Non-ICG 5mm Laparoscope (0 Deg)Smartsurgn Inc.HET2025-08-27
G465FG17000Non-ICG 5mm Laparoscope (30 Deg)Smartsurgn Inc.HET2025-08-27
00198506044229ELMED INCORPORATEDELMED INCORPORATEDHET2025-08-15
00198506084256ELMED INCORPORATEDELMED INCORPORATEDHET2025-07-24
04048223128121Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
04048223128145Cutting introducer cannula for Veress-Pajunk GmbH MedizintechnologieHET2025-06-17
EAMIICT50100i-Cut Power SupplyAMI Agency for Medical Innovations GmbHHET2025-05-05
EAMIICT50110i-CutAMI Agency for Medical Innovations GmbHHET2025-05-05
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00198506082542ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-30
00198506026096ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506026119ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027215ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00198506027222ELMED INCORPORATEDELMED INCORPORATEDHET2025-04-15
00817401029109EndoplusEndoplusHET2025-04-10
00198506081330ELMED INCORPORATEDELMED INCORPORATEDHET2025-03-17
00817401029093EndoplusEndoplusHET2025-03-14