FDA.reportPublic FDA data

NA

Primary DI
26932503533175
Brand
NA
Company
Micro-Tech (Nanjing) Co., Ltd.
Model
IN12-226232002
Catalog number
IN12-226232002
Device description
POM inner tuber，Needle Length 6mm，with metal cap 22G*6*2.3*200，Shroat stucture
Published
2016-03-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBKEndoscopic Injection Needle, Gastroenterology-Urology

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBKEndoscopic Injection Needle, Gastroenterology-UrologyGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150434000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150434000Injection NeedleMicro-Tech (Nanjing) Co., Ltd.2015-06-02FBK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
16932503533178PackageGS110In Commercial Distribution
26932503533175PackageGS110In Commercial Distribution
06932503533171PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1693250353317816932503533178
2693250353317526932503533175
06932503533171069325035331716932503533171

GMDN Terms#

Term, Definition table
TermDefinition
Submucosal injection needleA sterile, sharp bevel-edged, hollow tubular metal instrument intended to be used in conjunction with a syringe to administer substances (e.g., fluids, gels) into the submucosal layer of tissue (connective tissue layer beneath the mucosa), typically of anatomical structures with lumens. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length200Centimeter
Needle Gauge22Gauge

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
877-552-4027info@micro-tech-usa.com

Regulatory Flags#

DUNS number
530269083
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06932503563772eyeMAX(TM) Single-use Video Pancreaticobiliary ScopeCDS220092026-05-15
06932503516112Sphincterotome / short-wire compatibleRDSP-0525-121-12026-05-08
06932503516129Sphincterotome / short-wire compatibleRDSP-0525-221-12026-05-08
06932503516136Sphincterotome / short-wire compatibleRDSP-0525-131-12026-05-08
06932503516143Sphincterotome / short-wire compatibleRDSP-0525-231-12026-05-08
06932503516150Sphincterotome / short-wire compatibleRDSP-0530-111-12026-05-08
06932503516167Sphincterotome / short-wire compatibleRDSP-0530-211-12026-05-08
06932503516174Sphincterotome / short-wire compatibleRDSP-0530-121-12026-05-08
06932503516181Sphincterotome / short-wire compatibleRDSP-0530-221-12026-05-08
06932503516198Sphincterotome / short-wire compatibleRDSP-0530-131-12026-05-08
06932503516204Sphincterotome / short-wire compatibleRDSP-0530-231-12026-05-08
06932503575379Sphincterotome / short-wire compatibleRDSP-0220-1112026-05-08
06932503575386Sphincterotome / short-wire compatibleRDSP-0220-2112026-05-08
06932503575393Sphincterotome / short-wire compatibleRDSP-0220-1212026-05-08
06932503575409Sphincterotome / short-wire compatibleRDSP-0220-2212026-05-08
06932503575416Sphincterotome / short-wire compatibleRDSP-0220-1312026-05-08
06932503575423Sphincterotome / short-wire compatibleRDSP-0220-2312026-05-08
06932503575430Sphincterotome / short-wire compatibleRDSP-0225-1112026-05-08
06932503575447Sphincterotome / short-wire compatibleRDSP-0225-2112026-05-08
06932503575454Sphincterotome / short-wire compatibleRDSP-0225-1212026-05-08

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Primary DI, Brand, Company table
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