FDA.reportPublic FDA data

n.a.

Primary DI
04048551056615
Brand
n.a.
Company
Karl Storz GmbH & Co. KG
Model
13774H
Device description
Handhold HF asym polypectomy
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

Product Codes#

Code, Name table
CodeName
KGEFORCEPS, BIOPSY, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGEForceps, Biopsy, ElectricGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04048551056615PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04048551056615040485510566154048551056615

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
315731430
Device count
1
DM exempt
false
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
04048551232378n.a.27033U27033U2025-08-11
04048551232781n.a.27047B27047B2025-08-11
04048551418123n.a.TC304USTC304US2025-08-11
04048551210567n.a.8574GY8574GY2018-09-04
04048551210574n.a.8574GZ8574GZ2018-09-04
04048551211281n.a.8587K8587K2018-09-04
04048551211427n.a.8588K8588K2018-09-04
04048551211694n.a.8590KC8590KC2018-09-04
04048551425749n.a.40410LH40410LH2025-07-10
04048551425756n.a.40410LS40410LS2025-07-10
04048551425763n.a.40410LG40410LG2025-07-10
04048551425770n.a.40410LC40410LC2025-07-10
04048551425787n.a.40410LL40410LL2025-07-10
04048551425794n.a.40410LF40410LF2025-07-10
04048551425800n.a.40410LR40410LR2025-07-10
04048438008867NA051111-10051111-102025-03-28
04048438008911NA051110-10051110-102025-03-28
04048551010242NA497HCS497HCS2025-03-28
04048551012468NA11900RA11900RA2025-03-28
04048551061343NA20090331200903312025-03-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18809327353290ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353313ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327353320ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355515ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
18809327355805ClearHemograsperFINEMEDIX CO.,LTD.KGE2026-03-24
06934415022309ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022316ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022323ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022347ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022354ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-19
06934415022118ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022125ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022149ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022156ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022163ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022170ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022187ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022194ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022279ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022286ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
06934415022293ZKSKBeijing ZKSK Technology Co.,LtdKGE2023-12-18
16932503548325MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548332MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548349MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548356MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548363MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
16932503548370MTMicro-Tech (Nanjing) Co., Ltd.KGE2022-12-31
04547410470420FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04
04547410470437FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04
14547410470441FUJIFILMFUJIFILM CORPORATIONKGE2022-03-04