FDA.reportPublic FDA data

N/A

Primary DI
30885825016587
Brand
N/A
Company
STRYKER SUSTAINABILITY SOLUTIONS, INC.
Model
N/A
Catalog number
NB12STF
Device description
Bladeless Trocar with Fixation Cannula
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
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NLMLAPAROSCOPE, GENERAL & PLASTIC SURGERY, REPROCESSED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NLMLaparoscope, General & Plastic Surgery, ReprocessedGastroenterology, Urology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063788000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063788000REPROCESSED ENDOSCOPIC TROCARS AND CANNULASAscent Healthcare Solutions2007-10-15NLM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30885825016587PackageGS16In Commercial Distribution
00885825016586PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3088582501658730885825016587
00885825016586008858250165868858250165860885825016586

GMDN Terms#

Term, Definition table
TermDefinition
Laparoscopic trocar blade, reprocessedA sterile, rigid, surgical instrument with a sharp pyramidal or conical point intended to puncture the abdominal wall to facilitate the introduction of a laparoscopic access cannula (not included) during laparoscopy. It is intended to fill the lumen of the laparoscopic access cannula, whereby following puncture it is withdrawn to provide a single-lumen access port to the abdominal cavity. This is a previously used single-use device that has been processed for an additional single-use patient application.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length100Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature054 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(888)888-3433RegulatoryAffairs2@stryker.com

Regulatory Flags#

DUNS number
020198912
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327688788N/APSCIC101PSCIC1012026-04-06
07613327688764N/AAFR-00006AFR-000062026-02-10
07613327681710N/AR7219-RPR7219-RP2026-02-11
07613327687217N/AM004PF41M444M004PF41M4442025-12-16
07613327688795N/AD133701D1337012025-12-16
00850043377092Aquamantys23-112-123-112-12024-05-16
00850043377085Aquamantys23-313-123-313-12024-05-16
00850043377108Aquamantys23-113-123-113-12024-05-16
07613327682045N/AM004PF41M434M004PF41M4342025-09-29
00885825011703N/AN/A4083092016-09-23
00885825011710N/AN/A4083102016-09-23
00885825011727N/AN/AG4083242016-09-23
07613327663365N/AHAR723HAR7232025-08-27
07613327663389N/AHAR736HAR7362025-08-27
07613327663419N/AHAR745HAR7452025-08-27
37613327663366N/AHAR723HAR7232025-08-27
37613327663380N/AHAR736HAR7362025-08-27
37613327663410N/AHAR745HAR7452025-08-27
07613327487640N/AHM39SPU-HLFHM39SPU-HLF2019-07-10
07613327487671N/AHM50RPSPUHM50RPSPU2019-07-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277385511MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-07-18
10888277386167MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-04-17
20888277386164MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-04-17
10888277386761MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-03-01
20888277386768MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-03-01
10888277372450MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-02-14
10888277384484MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-02-14
20888277372457MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-02-14
20888277384481MEDLINE RENEWALMEDLINE INDUSTRIES, INC.NLM2025-02-14
10888277372597MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-31
20888277372594MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-31
10080196374649MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10193489000597MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277372443MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277372474MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277373976MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277373990MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374027MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374577MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374584MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374591MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374607MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277374614MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376632MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376649MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376656MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376663MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277376670MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277377776MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29
10888277378742MEDLINEMEDLINE INDUSTRIES, INC.NLM2025-01-29