FDA.reportPublic FDA data

HELMUT ZEPF

Primary DI
EZPF19600180
Brand
HELMUT ZEPF
Company
Helmut Zepf Medizintechnik GmbH
Model
19.600.18
Catalog number
19.600.18
Device description
APPLICATOR, GAUZE PACKER, LUNIATSCHEK, COTTON PLUGGER NARROW, 1,8 MM, 17,5 CM LONG
Published
2022-11-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KXFAPPLICATOR, ABSORBENT TIPPED, NON-STERILE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KXFApplicator, Absorbent Tipped, Non-SterileGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EZPF19600180PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Periosteal elevator, reusableA hand-held manual surgical instrument designed to lift/separate (elevate) or tunnel under the periosteum during surgery, typically orthopaedic, including use on the ribs. It may in addition be used in dentistry to access retained roots, or to remove them with surrounding bone. It is typically a one-piece instrument available in a variety of sizes and blade designs, including straight and curved blades, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49742498880info@zepf-dental.com

Regulatory Flags#

DUNS number
320001431
Device count
1
DM exempt
false
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
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EZPF2305412HZU0HELMUT ZEPF23.054.12HZU23.054.12HZU2025-03-10
EZPF33750010HELMUT ZEPF33.750.0133.750.012025-03-10
EZPF3375001F0HELMUT ZEPF33.750.01F33.750.01F2025-03-10
EZPF33750020HELMUT ZEPF33.750.0233.750.022025-03-10
EZPF33760020HELMUT ZEPF33.760.0233.760.022025-03-10
EZPF33760030HELMUT ZEPF33.760.0333.760.032025-03-10
EZPF33760110HELMUT ZEPF33.760.1133.760.112025-03-10
EZPF33760200HELMUT ZEPF33.760.2033.760.202025-03-10
EZPF33760210HELMUT ZEPF33.760.2133.760.212025-03-10
EZPF1704503HZU0HELMUT ZEPF17.045.03HZU17.045.03HZU2025-03-07
EZPF1742301HZU0HELMUT ZEPF17.423.01HZU17.423.01HZU2025-03-07
EZPF1742302HZU0HELMUT ZEPF17.423.02HZU17.423.02HZU2025-03-07
EZPF2474403LM5HZU0HELMUT ZEPF24.744.03LM5-HZU24.744.03LM5-HZU2025-03-07
EZPF2474405GHZU0HELMUT ZEPF24.744.05G-HZU24.744.05G-HZU2025-03-07
EZPF2474408HZU0HELMUT ZEPF24.744.08HZU24.744.08HZU2025-03-07
EZPF2474411GHZU0HELMUT ZEPF24.744.11G-HZU24.744.11G-HZU2025-03-07
EZPF2474413GHZU0HELMUT ZEPF24.744.13G-HZU24.744.13G-HZU2025-03-07
EZPF2474455HZU0HELMUT ZEPF24.744.55HZU24.744.55HZU2025-03-07
EZPF2474460HZU0HELMUT ZEPF24.744.60HZU24.744.60HZU2025-03-07
EZPF2474465HZU0HELMUT ZEPF24.744.65HZU24.744.65HZU2025-03-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
57613327680756Q-CareSAGE PRODUCTS, LLCKXF2025-12-03
30889483563278BALLARD™SUNMED, LLCKXF2025-11-17
30889483563292BALLARD™SUNMED, LLCKXF2025-11-17
10889483563304BALLARD™SUNMED, LLCKXF2025-11-17
30889483563322BALLARD™SUNMED, LLCKXF2025-11-17
30889483563346BALLARD™SUNMED, LLCKXF2025-11-17
30889483565524BALLARD™SUNMED, LLCKXF2025-11-17
30889483565531BALLARD™SUNMED, LLCKXF2025-11-17
30889483565548BALLARD™SUNMED, LLCKXF2025-11-17
M220761003Pro AdvantageNATIONAL DISTRIBUTION & CONTRACTING, INC.KXF2025-09-11
D832600BA4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BR4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
D832600BSF4000MAXAPPLICATOR IIPLASDENT CORPORATIONKXF2025-08-01
00840456214893JMUJMU DENTAL, INCKXF2025-07-15
00840456214909JMUJMU DENTAL, INCKXF2025-07-15
00840456214930JMUJMU DENTAL, INCKXF2025-07-15
00840456209127JMUJMU DENTAL, INCKXF2025-06-17
00840456209134JMUJMU DENTAL, INCKXF2025-06-17
00840456209141JMUJMU DENTAL, INCKXF2025-06-17
00840456213742JMUJMU DENTAL, INCKXF2025-06-17
00840456213759JMUJMU DENTAL, INCKXF2025-06-17
00840456213766JMUJMU DENTAL, INCKXF2025-06-17
00840456213773JMUJMU DENTAL, INCKXF2025-06-17
00840456213780JMUJMU DENTAL, INCKXF2025-06-17
00840456213797JMUJMU DENTAL, INCKXF2025-06-17
00848253004037StomaSoft Cleaning SwabsFreudenberg Medical, LLCKXF2025-03-17
00854498007047SmartPracticeSmarthealth, Inc.KXF2025-02-17
30840330701458ProCureTwin Med, LLCKXF2024-11-14
30840330701465ProCureTwin Med, LLCKXF2024-11-14