FDA.report

Viper

Primary DI
00816734021729
Brand
Viper
Company
DIVERSATEK HEALTHCARE, INC.
Model
1204-15
Catalog number
1204-15
Device description
Fixed Wire Balloon Dilator
Published
2022-07-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KNQDilator, Esophageal

Product Code Classifications

CodeDeviceSpecialtyClass
KNQDilator, EsophagealGastroenterology, Urology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00816734021729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00816734021729008167340217298167340217290816734021729

GMDN Terms

TermDefinition
Gastrointestinal/biliary dilation balloon catheterA long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, and may be of the fixed-wire or wire-guided type. This is a single-use device.

Sterilization Methods

Method

Contacts

PhoneEmail
800-558-6408sales@diversatekhc.com

Regulatory Flags

DUNS number
030650113
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10816734023515BullDog®1203-401203-402025-12-05
00816734022825Zvu®ZVU-3ZVU-32020-11-06
M78312011161Diversatek Healthcare1201-1161201-1162025-11-14
00816734023433Diversatek HealthcareMANO-KITMANO-KIT2025-05-16
00816734023440Diversatek HealthcareHRIM-KITHRIM-KIT2025-05-16
00816734023457Diversatek HealthcareHRIMSD-KITHRIMSD-KIT2025-05-16
00816734023464Diversatek HealthcareHRAM-KITHRAM-KIT2025-05-16
00816734023471Diversatek HealthcareEMG-KITEMG-KIT2025-05-16
00816734023488Diversatek HealthcareCOMP-KITCOMP-KIT2025-05-16
00816734023426Zvu®ZVU-3 Revision 3.4.0ZVU-32025-03-26
10816734023416BullDog®1203-931203-932024-11-22
M78312011101Diversatek Healthcare1201-1101201-1102024-10-31
10816734023362EZ-Ject1186-011186-012024-07-18
10816734023379EZ-Ject1186-021186-022024-07-18
10816734023386EZ-Ject1186-031186-032024-07-18
10816734023393EZ-Ject1186-041186-042024-07-18
M78312011081Diversatek Healthcare1201-1081201-1082024-06-07
M78312011061Diversatek Healthcare1201-1061201-1062024-01-31
10816734023355BullDog®1203-611203-612023-08-25
00816734023181SafeGuide® Single1215-151215-152023-08-14

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Primary DIBrandCompanyProduct codePublished
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56932503524037Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524044Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524051Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524068Rapide(TM) Multistage Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524075ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
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56932503524129ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
56932503524143ABC Dilatation Balloon CatheterMicro-Tech (Nanjing) Co., Ltd.KNQ2025-12-06
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00724995244545LumiflexUS EndoscopyKNQ2025-06-03
00724995244552LumiflexUS EndoscopyKNQ2025-06-03
00724995244569LumiflexUS EndoscopyKNQ2025-06-03
00724995244583LumiflexUS EndoscopyKNQ2025-06-03
00724995244590LumiflexUS EndoscopyKNQ2025-06-03
00724995244613LumiflexUS EndoscopyKNQ2025-06-03
00724995244644LumiflexUS EndoscopyKNQ2025-06-03
00724995244668LumiflexUS EndoscopyKNQ2025-06-03
00724995244675LumiflexUS EndoscopyKNQ2025-06-03
00724995244682LumiflexUS EndoscopyKNQ2025-06-03
16932503520673Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
16932503520680Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
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16932503520772Disposable Dilation BalloonMicro-Tech (Nanjing) Co., Ltd.KNQ2025-04-30
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